Liposomal Doxorubicin in Treating Children With Refractory Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019630
First received: March 1, 2007
Last updated: NA
Last verified: June 2002
History: No changes posted
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin in treating children who have refractory solid tumors.


Condition Intervention Phase
Childhood Soft Tissue Sarcoma
Childhood Liver Cancer
Bone Cancer
Brain Tumor
Kidney Tumor
Drug: doxorubicin HCl liposome
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Doxorubicin HCl Liposome in Pediatric Patients With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1999
Detailed Description:

OBJECTIVES: I. Determine the tolerance to and toxicity profile of doxorubicin HCl liposome (Lipodox) at standard doxorubicin doses and doses of Lipodox that were tolerable in adults administered every 3 weeks in pediatric patients with refractory solid tumors.

II. Determine the maximum tolerated dose of this drug in these patients if dose-limiting toxicity is observed at doses of 105 mg/m2 or less.

III. Determine the pharmacokinetics of this drug in these patients. IV. Assess the cardiotoxicity of this drug in children who have previously been treated with free doxorubicin and in children who have not previously received doxorubicin.

V. Evaluate the feasibility of using cardiac MRI functional imaging as a screening tool for the quantitative assessment of doxorubicin-induced cardiotoxicity.

VI. Determine if serum troponin t levels are a useful biomarker for doxorubicin-induced myocardial damage.

PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients receive doxorubicin HCl liposome IV over 60 minutes. Treatment repeats every 4 weeks for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 4-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 4 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL:

A total of 21-36 patients will be accrued for this study within 1-2 years.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically confirmed solid tumor, including but not limited to: Rhabdomyosarcoma and other soft tissue sarcomas Ewing's family tumors Osteosarcoma Neuroblastoma Wilms' tumor Hepatic tumors Germ cell tumors Primary brain tumors Histological confirmation for brain stem gliomas may be waived Refractory to standard treatment and no curative therapy available Measurable or evaluable disease Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery --Prior/Concurrent Therapy-- Biologic therapy: At least 1 week since prior colony-stimulating factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) At least 4 months since prior bone marrow transplantation No concurrent anticancer immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered Prior anthracyclines as adjuvant front-line therapy allowed provided: No relapse during therapy At least 6 months since last dose Cumulative dose is no greater than 400 mg/m2 for patients who received bolus administration without a concurrent cardioprotectant (e.g., dexrazoxane) or received cardiac irradiation and no greater than 450 mg/m2 for patients who received either continuous infusion or administration with a concurrent cardioprotectant and have not received cardiac irradiation No other concurrent anticancer chemotherapy Endocrine therapy: Concurrent corticosteroids for brain tumor-associated edema allowed (must be on stable or decreasing dose for at least 1 week prior to study) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No more than 1,500 cGy of prior cardiac radiotherapy No prior extensive radiotherapy (e.g., craniospinal radiation, total body radiation, or radiation to more than half of the pelvis) No concurrent anticancer radiotherapy Surgery: See Disease Characteristics Other: No other concurrent anticancer investigational agents No other concurrent liposomal formulations of any drug (e.g., liposomal amphotericin B) --Patient Characteristics-- Age: 21 and under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Hemoglobin greater than 8 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGPT no greater than 2 times upper limit of normal No significant hepatic dysfunction Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac ejection fraction at least 45% on MUGA (National Cancer Institute patients) OR Shortening fraction at least 28% on echocardiogram (Children's Hospital of Philadelphia patients) No significant or preexisting cardiac dysfunction (e.g., recurrent or persistent cardiac dysrhythmia or an ejection fraction below the lower limit of normal on MUGA or echocardiogram) Pulmonary: No significant pulmonary dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically significant unrelated systemic illness (e.g., serious infections or organ dysfunction) No allergy to doxorubicin or other anthracyclines, eggs, egg products, or other liposomal drug formulations

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019630

Locations
United States, Maryland
Pediatric Oncology Branch
Bethesda, Maryland, United States, 20892
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Study Chair: Elizabeth Lowe National Cancer Institute (NCI)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00019630     History of Changes
Obsolete Identifiers: NCT00001798
Other Study ID Numbers: CDR0000066924, NCI-99-C-0039F, LIPO-NCI-99-C-0039, NCI-99-C-0039
Study First Received: March 1, 2007
Last Updated: March 1, 2007
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Ewing's family of tumors
Wilms' tumor
adult solid tumor
body system/site cancer
bone cancer
brain tumor
cancer
central nervous system cancer
childhood brain stem glioma
childhood brain tumor
childhood cancer
childhood central nervous system germ cell tumor
childhood cerebellar astrocytoma
childhood cerebral astrocytoma
childhood choroid plexus tumor
childhood craniopharyngioma
childhood ependymoma
childhood extracranial germ cell tumor
childhood extragonadal malignant germ cell tumor
childhood liver cancer
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
childhood mature and immature teratomas
childhood medulloblastoma
childhood meningioma
childhood oligodendroglioma
childhood rhabdomyosarcoma
childhood soft tissue sarcoma
childhood solid tumor
childhood supratentorial primitive neuroectodermal and pineal tumors

Additional relevant MeSH terms:
Bone Neoplasms
Osteosarcoma
Brain Neoplasms
Kidney Neoplasms
Liver Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014